Medicine administering system including injection pen and companion device

ABSTRACT

Methods, systems, and devices are disclosed for administering a medicament to a patient. In one aspect, a system includes an injection pen device in wireless communication with a mobile communication device. The injection pen device includes a housing including a chamber to encase a cartridge containing medicine, a dose setting and dispensing mechanism to set the mechanism to dispense a particular dose of the medicine from the loaded cartridge, a sensor unit to detect a dispensed dose based on positions and/or movements of the dose setting and dispensing mechanism, and an electronics unit in communication with the sensor unit to process the detected dispensed dose and time data associated with a dispensing event and to wirelessly transmit the dose data to a user&#39;s device. The mobile communication device provides a software application to provide the user with health information using the processed dose data.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent document is a continuation of U.S. application Ser. No.15/613,851 entitled “MEDICINE ADMINISTERING SYSTEM INCLUDING INJECTIONPEN AND COMPANION DEVICE” filed on Jun. 5, 2017, which is a continuationof U.S. application Ser. No. 14/797,044 entitled “MEDICINE ADMINISTERINGSYSTEM INCLUDING INJECTION PEN AND COMPANION DEVICE” filed on Jul. 10,2015, now U.S. Pat. No. 9,672,328, issued Jun. 6, 2017, which claimspriorities to and benefits of U.S. Provisional Patent Application No.62/022,798 entitled “SYSTEM FOR ADMINISTERING A MEDICAMENT” filed onJul. 10, 2014, and U.S. Provisional Patent Application No. 62/162,572entitled “MEDICINE ADMINISTERING SYSTEM INCLUDING INJECTION PEN ANDCOMPANION DEVICE” filed on May 15, 2015. The entire content of the abovepatent applications is incorporated by reference as part of thedisclosure of this patent document.

TECHNICAL FIELD

This patent document relates to medicine administering systems, devices,and processes.

BACKGROUND

Diabetes mellitus, also referred to as diabetes, is a metabolic diseaseassociated with high blood sugar due to insufficient production or useof insulin by the body. Diabetes is widely-spread globally, affectinghundreds of millions of people, and is among the leading causes ofdeaths globally. Diabetes has been categorized into three categories ortypes: type 1, type 2, and gestational diabetes. Type 1 diabetes isassociated with the body's failure to produce sufficient levels ofinsulin for cells to uptake glucose. Type 2 diabetes is associated withinsulin resistance, in which cells fail to use insulin properly. Thethird type of diabetes is commonly referred to as gestational diabetes,which can occur during pregnancy when a pregnant woman develops a highblood glucose level. Gestational diabetes can develop into type 2diabetes, but often resolves after the pregnancy.

SUMMARY

Systems, devices, and techniques are disclosed for administeringmedicine to patients and providing health management capabilities forpatients and caregivers.

In one aspect, a system for administering a medicine to a patientincludes an injection pen device and a mobile communication device inwireless communication with the injection pen. The injection pen deviceincludes a housing including a main body structured to include a chamberto encase a cartridge containing medicine when the cartridge is loadedin the chamber, a dose setting and dispensing mechanism to set anddispense a particular dose of the medicine from the loaded cartridge,the dose setting and dispensing mechanism including a dose knob, ashaft, and a piston assembly including a plunger, in which the dose knobis rotatable to cause the shaft to move to a position proportional to aset dose of the medicine, and in which the dose knob is translationallymoveable to cause the shaft to drive the plunger to push against thecartridge to dispense the medicine from the cartridge, a sensor unit todetect a dispensed dose based on one or both of positions and movementsof the dose setting and dispensing mechanism, in which the dispenseddose includes an amount of medicine dispensed from the cartridge, and anelectronics unit in communication with the sensor unit, the electronicsunit including a processing unit including a processor and memory toprocess the detected dispensed dose and time data associated with adispensing event to generate dose data, a transmitter to wirelesslytransmit the dose data to a user's device, and a power source to provideelectrical power to the electronics unit. The mobile communicationdevice includes a data processing unit including a processor to processthe dose data and a memory to store or buffer the dose data, a displayto present a user interface to the user, and a wireless communicationsunit to wirelessly receive the dose data from the injection pen device.

In one aspect, a method to classify a dose of medicine dispensed from aninjection pen includes detecting one or more doses of medicine dispensedfrom an injection pen device and time data associated with the one ormore dispensed doses to generate dose data corresponding to dispensingevents; processing the dose data corresponding to one or more dispensingevents over a predetermined duration of time to form a dose dispensingsequence; and determining a type of dispensing event as a priming eventor an injection event for the dose data in the dose dispensing sequenceby assigning a last dispensing event in the dose dispensing sequence asthe injection event and any previous dispensing events in the dosedispensing sequence as the priming events.

In one aspect, a method to classify a dose of medicine dispensed from aninjection pen includes detecting one or more doses of medicine dispensedfrom an injection pen device and time data associated with the one ormore dispensed doses to generate dose data corresponding to dispensingevents, in which the detecting includes sensing a rate at which themedicine is dispensed from the injection pen device; processing the dosedata corresponding to one or more dispensing events over a predeterminedduration of time to form a dose dispensing sequence; comparing the rateof the one or more dispensed doses for each of the dispensing events inthe dose dispensing sequence to a predetermined dispensing ratethreshold; and determining a type of dispensing event as a priming eventfor a dispensing event in the dose dispensing sequence when thecorresponding sensed rate is slower than the predetermined dispensingrate threshold, and determining the type of dispensing event as aninjection event for a dispensing event in the dose dispensing sequencewhen the corresponding sensed rate is faster than the predetermineddispensing rate threshold.

In one aspect, a method of unbonding an injection pen device from amobile communication device includes providing instructions to a user ofthe injection pen device that has been communicatively bonded to a firstmobile communication device to perform an operation sequence includingtwo or more operations of the injection pen device in a predeterminedtime frame; initiating, by a processing unit of the injection pendevice, a count of the predetermined time frame once a dose settingmechanism of the injection pen device is set at or greater than a firstlevel; detecting, by the injection pen device, operations of the dosesetting and a dose dispensing mechanism of the injection pen device; andclearing encryption keys stored in the processing unit of the injectionpen device associated with the first mobile communication device whenthe operation sequence is detected within the predetermined time.

In some aspects, an intelligent medicine administration system includesa medicine injection device, in communication with a patient's companiondevice (e.g., smartphone), in which the injection device is able todetect and record dose sizes that are dispensed (e.g., primed orinjected to the patient), and to distinguish between a prime dose and atherapy dose. The companion device can include a software applicationhaving a dose calculator that can suggest the dose the patient shouldset on the injection device, and provides control over severalfunctionalities of the injection device (e.g., safety lock, assisted bythe dose distinguisher). Multiple embodiments of the injection deviceinclude various features, including a sensor to detect when the deviceis being operated, a sensor to detect the dose setting, a sensor tomonitor temperature of the injection device, data processing, storageand communication capabilities, and control and messaging (e.g., alert)features to affect the patient's operation of the device.

The intelligent medicine administration system of the present technologyis also capable of keeping track of doses that have been administered.In some implementations, for example, a method of tracking usage of amedicament by a patient through a pen device, where the medicament isadministered from the pen in a plurality of boluses over time, isprovided. In this method, information is recorded about the medicamentadministration and the information is stored on a companion device. Insome embodiments, for example, the information comprises the quantityand time of each administered bolus of the medicament. The pen andcompanion device are in communication and allow the patient to use thepen to deliver one or more boluses with the pen, in which the pen canautomatically store information associated with each delivered bolus,e.g., including at a minimum the amount of the bolus and the time atwhich the bolus was delivered, and/or determine the time relatedinformation with the bolus, and transmit that information to thecompanion device.

Medication tracking systems are needed in critical care and ambulanceenvironments, for example, where continuity of medication trackingacross health care teams is needed. In this case, a patient record ofdosing could be transferred with the patient from one care team (e.g.paramedics) to a second care team (e.g. ER staff). This informationcould be transferred by transferring a device with the patient orsending the data to the cloud based medical record for the patient, forexample.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a block diagram of an exemplary pen device of thedisclosed intelligent medicine administration system.

FIG. 1B shows a block diagram of an exemplary embodiment of thecompanion device of the disclosed intelligent medicine administeringsystem.

FIGS. 2A-2F show display screens of an exemplary user interface of asoftware application resident on the companion device of the disclosedintelligent medicine administering system.

FIG. 3A shows a flow chart diagram of an exemplary method of bonding andunbonding a pen device from a companion device.

FIG. 3B shows a diagram of an exemplary method of unbonding a pen devicefrom a companion device.

FIGS. 4 and 5 show schematic diagrams of an exemplary embodiment of apen device of the disclosed technology.

FIGS. 6A and 6B show diagrams of exemplary methods to classify a dose ofmedicine dispensed from an injection pen.

DETAILED DESCRIPTION

There are many different diseases and conditions that require a patientto self-administer doses of a fluid medication. Typically, whenadministering a fluid medication, the appropriate dose amount is set anddispensed by the patient using a syringe, a pen, or a pump. For example,self-administered medicaments or medicine include insulin used to treatdiabetes, Follistim® used to treat infertility, or other injectablemedicines such as Humira®, Enbrel®, Lovenox® and Ovidrel®, or others.

A medicament pen, also referred to as a pen, is a device that can beused to inject a quantity of a medicine (e.g., single or multipleboluses or doses of the medicine) into a user's body, where more thanone dose can be stored in a medicine cartridge contained in the pendevice. Pens offer the benefit of simplicity over other methods ofdelivery, such as syringe or pump based methods. For example, syringestypically require more steps to deliver a dose, and pumps typically aremore complicated to use and require a constant tether to the patient.However, previously there has been no automated way to track andcommunicate the doses given with the pen in a simple manner. Inaddition, it can be difficult to know how much to dose, when to dose, orif the patient dosed at all.

As with the dosing of any medication, it is sometimes hard to rememberif a dose has been given. For this reason pill reminders have beendeveloped where the patient places the medication for the day in a cuplabeled with that day. Once they take their medication there is noquestion it has been taken because the pills are no longer in the cup.Yet, there are no widely acceptable solutions that address this problemfor injection-based therapies.

Disclosed are intelligent medicine administering systems to providehealth management capabilities for patients and caregivers. In someaspects, a system includes a medicine injection device, in communicationwith a patient's companion device (e.g., smartphone), in which theinjection device is able to detect and record dose sizes that aredispensed (e.g., primed or injected to the patient), and to distinguishbetween a prime dose and a therapy dose. The companion device caninclude a software application having a dose calculator that can suggestthe dose the patient should set on the injection device, and providescontrol over several functionalities of the injection device (e.g.,safety lock, assisted by the dose distinguisher, and pen and companiondevice bonding, among other functionalities). Multiple embodiments ofthe injection device include various features, including a sensor todetect when the device is being operated, a sensor to detect the dosesetting, a sensor to monitor temperature of the injection device, dataprocessing, storage and communication capabilities, and control andmessaging (e.g., alert) features to affect the patient's operation ofthe device.

Communication between the pen device and the companion device providesthe ability for dose tracking, logging, calculation and communication ofdose data with a user, and other advantages of the intelligent medicineadministering system. For example, each bolus that is dispensed by thepen device can be automatically logged and communicated to the companiondevice.

FIG. 1A shows a block diagram of an exemplary embodiment of a pen device10 of the disclosed intelligent medicine administering system. The pen10 is structured to have a body which contains the medicine cartridge(e.g., which can be replaceable), and to include a mechanism to dispense(e.g., deliver) the medicine, a mechanism to select or set the dose tobe dispensed, a mechanism to determine that the device is being operatedand/or to monitor the operation of the dose being dispensed (e.g., suchas a switch and/or sensor, or an encoder), and an electronics unit thatcan include a processor, a memory, a battery or other power source, anda transmitter.

The pen 10 is configured in communication with a user's mobile computingand communication device 5, e.g., such as the user's smartphone, tablet,and/or wearable computing device, such as a smartwatch, smartglasses,etc., and/or a user's laptop and/or desktop computer, a smarttelevision, or network-based server computer.

In some implementations of the disclosed medicine administering system,for example, to use the pen 10, the user first dials up a dose using adose knob. The dose knob of the pen 10 can be included as part of thedose setting mechanism and/or the dose dispensing mechanism. Forexample, the dose may be adjusted up or down prior to administration ofthe dose. When the user applies a force against a dose dispensing button(e.g., presses against the dose dispensing button that is caused toprotrude outward from the pen's body upon dialing the dose using thedose knob), a pushing component (e.g., also referred to as a ‘plunger’)of the dose dispensing mechanism is depressed against an abutment of themedicine cartridge loaded in the pen 10 to cause the pen 10 to begin todispense the medicine, in which the quantity dispensed is in accordancewith that set by the dose setting mechanism. In such implementations,the operations monitoring mechanism of the pen 10 will begin to sensemovement of a rotating component or shaft that drives the plunger, forexample, in which the movement is sensed through an encoder. In someexamples, the encoder can be configured to sense the rotation of acomponent that is coupled to the drive shaft, and as the drive shaftrotates it moves linearly; and therefore by sensing rotation of thecomponent, the movement of the drive shaft and the plunger is sensed.Movement of the encoder may be detected as data processed by a processorof the electronics unit of the pen 10, which can be used to measure thedose. In some implementations, the processor can then store the size ofthe dose along with a time stamp for that dose. In some implementations,the pen 10 can then transmit the dose and related information to thecompanion device 5. In such implementations when the dose istransmitted, the data associated with the particular transmitted dose ismarked in the memory of the pen 10 as transmitted. In suchimplementations if the dose was not yet transmitted to the companiondevice 5, then the data associated with the dose will be transmitted atthe next time a successful communication link between the pen 10 and thecompanion device 5 is established.

The dose setting mechanism of the pen 10 can include a sensor that canutilize any method of sensing rotary or linear movement. Non-limitingexamples of such sensors include rotary and linear encoders, Hall effectand other magnetic based sensors, linearly variable displacementtransducers, or any other appropriate method of sensing known in theart.

The dose dispensing mechanism of the pen 10 can include a manuallypowered mechanism or a motorized mechanism. In either case, a force(e.g., either produced by the patient or by an electrically-poweredmotor) pushes on the plunger of the dose dispensing mechanism to in turnforce a receiving plunger of the medicament vial or cartridge to deliverthe specific amount of the medicament. In some implementations, forexample, the dose dispensing mechanism can be adjusted to deliver thedose over a different period of time. In one example, the dosedispensing mechanism can be operated such that the plunger is pushed inby an adjustable tension spring or change the speed of the motor toinject the dose over a time frame (e.g., 1 s, 5 s or other) to aid inthe pain of dosing. In one example, the dose dispensing mechanism can beoperated over a much longer period of time, e.g., to better match thedynamics of carbohydrates, which can be like an extended bolus with apump.

The companion device 5 includes a software application, which whenloaded on the companion device 5, provides a user interface to allow theuser to manage his/her health related data. In some implementations, forexample, the companion device 5 can be configured to control somefunctionalities of the pen device 10. In some implementations, forexample, the companion device 5 includes the user's existing smartphone,tablet, or wearable computing device. In some implementations, forexample, the companion device 5 is an independent portable device thatthe user may carry on his/her person. In one example embodiments of anindependent portable companion device 5, the companion device 5 includesa data processing unit, wireless communication unit to allow the deviceto communicate with the pen device 10, and a display unit.

FIG. 1B shows a block diagram of an exemplary embodiment of thecompanion device 5 of the disclosed intelligent medicine administeringsystem. The data processing unit of the companion device 5 includes aprocessor to process data, a memory in communication with the processorto store data, and an input/output unit (I/O) to interface the processorand/or memory to other modules, units or devices of the companion device5 or external devices. For example, the processor can include a centralprocessing unit (CPU) or a microcontroller unit (MCU). For example, thememory can include and store processor-executable code, which whenexecuted by the processor, configures the data processing unit toperform various operations, e.g., such as receiving information,commands, and/or data, processing information and data, and transmittingor providing information/data to another device. In someimplementations, the data processing unit can transmit raw or processeddata to a computer system or communication network accessible via theInternet (referred to as ‘the cloud’) that includes one or more remotecomputational processing devices (e.g., servers in the cloud). Tosupport various functions of the data processing unit, the memory canstore information and data, such as instructions, software, values,images, and other data processed or referenced by the processor. Forexample, various types of Random Access Memory (RAM) devices, Read OnlyMemory (ROM) devices, Flash Memory devices, and other suitable storagemedia can be used to implement storage functions of the memory unit. TheI/O of the data processing unit can interface the data processing unitwith the wireless communications unit to utilize various types of wiredor wireless interfaces compatible with typical data communicationstandards, for example, which can be used in communications of the dataprocessing unit with other devices such as the pen device 10, via awireless transmitter/receiver (Tx/Rx) unit, e.g., including, but notlimited to, Bluetooth, Bluetooth low energy, zigbee, IEEE 802.11,Wireless Local Area Network (WLAN), Wireless Personal Area Network(WPAN), Wireless Wide Area Network (WWAN), WiMAX, IEEE 802.16 (WorldwideInteroperability for Microwave Access (WiMAX)), 3G/4G/LTE cellularcommunication methods, and parallel interfaces. The I/O of the dataprocessing unit can also interface with other external interfaces,sources of data storage, and/or visual or audio display devices, etc. toretrieve and transfer data and information that can be processed by theprocessor, stored in the memory unit, or exhibited on an output unit ofthe companion device 5 or an external device. For example, a displayunit of the companion device 5 can be configured to be in datacommunication with the data processing unit, e.g., via the I/O, toprovide a visual display, an audio display, and/or other sensory displaythat produces the user interface of the software application of thedisclosed technology for health management. In some examples, thedisplay unit can include various types of screen displays, speakers, orprinting interfaces, e.g., including but not limited to, light emittingdiode (LED), or liquid crystal display (LCD) monitor or screen, cathoderay tube (CRT) as a visual display; audio signal transducer apparatusesas an audio display; and/or toner, liquid inkjet, solid ink, dyesublimation, inkless (e.g., such as thermal or UV) printing apparatuses,etc.

In operation of the disclosed intelligent medicine administering system,for example, when a dosing event (e.g., an amount of fluid is dispensedfrom the pen device 10), a time stamp associated with the dispensing isreferenced is recorded by the processing unit of the pen 10 (e.g.,stored in the memory of the pen 10). For example, the time stamp may bethe current time or a time where a count-up timer is used. When the doseinformation is eventually transmitted to the companion device 5, thetime stamp and/or a ‘time-since-dose’ parameter is transmitted by thepen 10 and received by the companion device 5 and stored in the memoryof the data processing unit of the companion device 5. In someimplementations, for example, the time of the dose can be determinedwithout the pen having to know the current time. This can simplifyoperation and setup of the pen 10. In some implementations, for example,a user time is initialized on the pen 10 from the companion device 5, inwhich the user time is used for dose time tracking. Using the disclosedsystem, the companion device 5 can know the time of the dose relative tothe current time.

Once the companion device 5 receives the dose related information (e.g.,which can include the time information and dose setting and/ordispensing information, and other information about the pen 10 relatedto the dosing event), the companion device 5 stores the dose relatedinformation in memory, e.g., which can include among a list of doses ordosing events. For example, via the software application's userinterface, the companion device 5 allows the patient to browse a list ofprevious doses, to view an estimate of current medicament active in thepatient's body (“medicament on board”) based on calculations performedby a medicine calculation module of the software application, and/or toutilize a dose calculation module of the software application to assistthe patient regarding dose setting information on the size of the nextdose to be delivered. For example, the patient could enter carbohydratesto be eaten, current blood sugar, and the companion device 5 wouldalready know insulin on board. Using these parameters a suggestedmedicine dose (e.g., such as insulin dose), calculated by the dosecalculation module, may be determined. In some implementations, forexample, the companion device 5 can also allow the patient to manuallyenter boluses into the pen device 10 or another medicine deliverydevice. This would be useful if the patient was forced to use a syringe,or if the battery in the pen device 10 was depleted.

Exemplary embodiments and implementations of the disclosed intelligentmedicine administering system are described.

User Settable Dose Calculator: For Example, Type 2 Diabetes DoseCalculations

In some implementations, when the medicine includes insulin fortreatment of diabetes, for example, the dose calculator can beconfigured for patients with Type 2 diabetes. Several protocols can beused to treat such patients using the disclosed intelligent medicineadministering system, including a “sliding scale” feature on thesoftware application of the companion device 5. In an example, a slidingscale dose calculator is provided by the software app and configured tobe user settable by the patient user of the companion device 5 and pendevice 10 (and/or accessible and settable by a healthcare provider tothe patient) to allow the patient to tailor or design the inputparameters of the dose calculator to their specific needs andcircumstances. In an illustrative example, some Type 2 diabetic patientsmight replace a specific carbohydrate input (e.g., grams or caloriesfrom carbohydrates ingested) with a 3-position switch or buttonsassociated with “small”, “medium”, and “large” meals. In suchimplementations, the software application provides a menu to allow auser to select from existing fields of entry (e.g., such as the ‘slidingscale’ of meal sizes), and/or provide suggestions for new fields to becreated for the dose calculator.

Multiple Pen Devices for Multiple Medicaments: Daily Dose Calculator,Drug Confusion Alerts, and Glucagon Delivery and Calculator

In some cases regarding diabetes, for example, more than one medicamentmay be used in the treatment of diabetes. For example, long and shortacting insulins may both be taken. These insulins may both be taken oneor several times throughout the day. In some implementations, thecompanion device 5 is configured to receive signals from two or more pendevices 10. Each pen would be dedicated to deliver a particularmedication, e.g., such as a short acting insulin (e.g., Humalog®,NovoLog®, Apidra®, or other) or long acting insulin (e.g., Lantus®,Levemir®, Toujeo®, or other). For example, the disclosed intelligentmedicine administering system can be configured to allow having pens formore than one diabetes medication, which can include some additionalfeatures of the companion device 5. First, the software applicationresident on the companion device 5 can include a Total Daily DoseCalculation module, in which a total daily dose is determined to be theaverage sum of all insulin delivered (e.g., both long and short acting)in a day. This average may be calculated over different periods of timelike week, month, quarter, etc. In addition, the software applicationresident on the companion device 5 can include drug confusion alertsthat can be provided to the user via the display unit of the companiondevice 5. For example, with a drug confusion alert, the companion device5 can alarm the patient if the patient injects a drug at the wrong time(e.g., because it indicates that there was confusion on which pen devicethe patient used). Also, for example, if the patient typically injectslong acting insulin in the morning and delivers a dose in the afternoon,a mistake likely occurred. The typical delivery time could be set eitherexplicitly (e.g., set a typical time and window for that delivery time)or experimentally where the average delivery time and typical window areanalyzed to determine if a dose differs from the normal pattern. Drugconfusion alerts can also be used in the hospital setting where aninjection (or planned injection) can be cross checked with theElectronic Medical Record (EMR) or physician order to determine if thedose was correctly delivered, if there is a possible drug interaction,etc.

Another drug that can be used in the treatment of diabetes is glucagon.Glucagon raises the blood sugar. For example, if a patient's blood sugarstarts to go low either because of too much insulin, too little food,too much exercise, or due to any of a variety of other factors, thepatient may give himself/herself some glucagon to raise the blood sugar.Currently, Glucagon is typically delivered in a 1 mL rescue dose.However, it is anticipated that in the near future, microdosed glucagoncan be delivered in only the volumes needed, and such microdosedglucagon vials will be developed. The disclosed intelligent medicineadministration system is capable of tracking glucagon delivery. Thetracking of glucagon can provide several advantages. First, there wouldbe a record of the medication for health care providers. Currently thereis no electronic record of glucagon deliveries. Second, any dosedglucagon should be considered in a dose calculator for future doses. Thepen device 10 can be configured to store microdosed glucagon cartridgesand detect, process, and/or transmit such dispensings with the companiondevice 5. For example, the disclosed intelligent medicine administeringsystem can include one or more pen devices 10 configured to store anddispense the patient's diabetes medications from the medicine cartridge,e.g., insulins, and one or more pen devices 10 configured to store anddispense the patient's microdosed glucagon from the cartridge. Thesoftware application of the companion device 5 can include glucagon indose calculations of the patient's proper next insulin dose and/ordetermine or set a glucagon dose, e.g., by considering a “Glucagon onBoard” amount. This amount can be determined in the same way as insulinon board is currently determined using the software application.However, the action time of glucagon is much shorter. The dosecalculator would include a “glucagon factor” or “Glucagon SensitivityFactor” which can describe the patient's blood sugar response toGlucagon, e.g., in mg/dL/mL or mmol/L/mL or other specified units. Thisfactor can be used both to determine a future rise in blood sugar due torecently injected glucagon as well as an amount of required glucagonprior to injection. By using the exemplary equation: Rise in bloodglucose=Glucagon dose×Glucagon Factor; the calculator can determine theamount of glucagon required to raise the blood sugar a desired amount.This desired amount can be entered by the user or determined by the dosecalculator based on excess “Insulin on Board”.

Similarly, other drugs would benefit from the disclosed technology aswell. For example, Follistim® is a drug used to treat infertility. Inthe case of Follistim, the typical dosing is a once or more a dayregimen for several days. This regimen will begin several days followinga woman's menstrual cycle. This dosing regimen is hard to remember. Inthis example case, a dose aid can be provided where the woman recordsher cycle. The aid then shows what days to take the drug. If the dose isgiven on those days, no alarm sounds. If the dose is not given by aparticular time (e.g., perhaps user entered, or physician entered), thenan alarm can sound to remind the user to take the dose. If a dose isgiven on an incorrect day, then an alarm is sounded to warn the user ofthis as well. Because infertility treatment is expensive,implementations of drug dose setting and delivery tracking by thedisclosed technology can include using a data network (e.g., cellular,Wi Fi or other) to communicate the dosing history and especially dosingproblems to the patient's treating physician (e.g., database at thetreating physician's office) so that they may follow up with the patientif desired.

In another example, other drugs that can benefit from dose reminders ofthe disclosed technology include Lovenox®, Enbrel®, Humira®, and others.In addition, the software app of the companion device 5 may provide asymptom tracking feature for the patient to input and track symptomsthat the drug is intended to alleviate so that there is a better recordof symptoms for the physician to make drug choice and dosing decisions.Additionally, the symptom tracking feature can allow the patient torecord side effects associated with use of the drug. In implementationsfor symptom tracking and/or side effect tracking, for example, the userinterface of the software application can provide a menu of possiblesymptoms or side effects which makes tracking easier. For example, ifheadache is a common side effect, the menu might provide a slider forheadache with limits including none and extreme so the user just movesthe slider to the appropriate area and leaves it. Side effect andsymptom information could be transmitted real time to the user'scaregiver (e.g., user's doctor office), and/or can be stored for laterreview during an office visit or transmitted only if a specificthreshold is reached. For example, the software application might ask ifa user has experienced shortness of breath and any answer of “yes” or ona sliding scale “moderate” or more might be automatically transmitted tothe physician.

Because multiple drugs may be used with the product, multiple detectionfeatures for ensuring that the correct drug is loaded can be included inthe pen device 10 and/or companion device 5. For example, there may beseveral drugs that are desired to use and in this case knowing whichdrug is loaded is useful. Drug cartridges are provided with unique codeson the cartridges such as bar codes. The companion device 5 can includea camera to capture an image of the bar code on a medicine cartridgethat can be processed by the data processing unit to identify the typeof drug being loaded. For example, the processed data associated withthe image captured by the camera of the coded cartridge can be used bythe processing unit to identify the actual drug being loaded andgenerate an alarm if an incorrect or wrong drug is being loaded (e.g.,based on data provided by the patient using a user setting of correctdrugs), or confirm that the correct drug is being loaded. In the case ofuse of multiple drugs, the software application can be configured toprovide features and the interface associated with a particular drugloaded, e.g., in accordance with the correct drugs listed for thespecific patient. For example, different dose calculation parameters,different tracking parameters, or metrics can be stored, and/oridentification of each dose tracked as having come from that drug. In anillustrative example, if the user uses two types of insulin, in whichone type has an action time of 3 hours and the other type has an actiontime of 5 hours, then the device 10 can detect which drug the user isloading and provide that parameter to the dose calculator algorithmautomatically.

Dose Distinguisher

Patients may need to dispense a prime or priming dose prior to injectingthe therapy or therapeutic dose. For example, in some use cases, thepatient will replace their needle and deliver a prime dose intended toclear the new needle of air. In some cases, for example, a prime dosewill be delivered even though the needle was not replaced. In somecases, for example, a prime dose will not be delivered even though theneedle was replaced. It is necessary to be able to determine which dosesare the prime doses and which are therapeutic doses, in which dataassociated with the determination of the dose type should be included inthe dose calculation (e.g., “Insulin on Board” calculation) and thetherapy analytics. Typically, when a prime dose is delivered, it isfollowed by a therapy dose. In some implementations of the intelligentmedicine administering system, for example, the software application ofthe companion device 5 can include a dose distinguisher oridentification module to process dose dispensing data and determine anddistinguish between a prime dose and a therapy dose that was dispensedfrom the pen device 10. In some implementations of the intelligentmedicine administering system, for example, the data processing unit onthe pen device 10 can include the dose distinguisher module to processdose dispensing data and determine and distinguish between a prime doseand a therapy dose that was dispensed from the pen device 10.

In some embodiments, the dose distinguisher module is configured toimplement a dose classification method to group data associated withdispensed medicine doses and classify the dispensed doses in the groupas either a prime dose or an injected (e.g., therapy) dose; such that,for any group of doses happening in close temporal proximity, only thelast dose is recorded as a therapeutic dose. The close temporalproximity is a predetermined temporal threshold value, e.g., which canbe defined as 10 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, or10 minutes or other.

Identifying doses as prime is very important in patients with lowinsulin requirements. For example, in a child, a typical prime dose maybe 2 units while a typical therapy dose may be 0.5 or 1 units. In thiscase, if a user were to include all dispensed insulin in the tracking(rather than only the therapeutic insulin), then the therapy trackingwould be wrong as would any insulin on board calculations or future doserecommendations. This is one example showing that prime doses cannot bedistinguished based solely on size. In the example given above, thetherapy dose is much smaller than the prime dose, but with a fully grownadult or a type 2 patient, the therapy dose may be much larger than theprime.

In some cases, for example, a user may prime their device and notdeliver a therapeutic dose. To prevent the dose distinguisher modulefrom improperly identifying the dose as a therapeutic dose, in suchcases, the system can include an additional mechanism that may beutilized to quickly identify the dose as either “prime” or“therapeutic”. In one example of this additional dose identificationmechanism, a user verification input can be included in the softwareapplication of the companion device 5 to allow the patient to identifythat the recorded doses were one of the prime or therapy doses, whichwould then allow for such doses to be included in any therapy analyticsand insulin on board calculation, as appropriate. This user verificationinput mechanism can include a radio button, a toggle switch, and/orgraphic of the user interface allowing tapping on the dose, slider, orother mechanism.

In some embodiments, for example, the dose distinguisher module can beconfigured to include one or more additional processes or exceptions tothe exemplary dose classification method to group and classify the lastdose of a group of doses happening in close temporal proximity as atherapeutic dose. In an example, the dose classification method can beimplemented such that following a cartridge replacement, if there isonly a single dose, it would be designated a prime dose and not atherapy dose. In another example, the dose classification method can beimplemented such that when a first dose (or intermediate dose) is largerthan a predetermined dose quantity threshold, that dose is consideredtherapy. For example, any dose determined to be larger than 2, 5, 10units or other size could be considered therapy regardless of theirposition in the dose sequence.

The dose distinguisher module of the disclosed systems to determineprime doses from therapeutic doses can include a separate dosing knob onthe pen device 10 for prime dosing. The exemplary separate dosing knobcan be structured to actuate the dose jackscrew, but not the doseencoder (as described later in this patent document). In theseembodiments, for example, when the user rotates the separate dose knob,the medicine is injected but the encoder does not count the dose.

The dose distinguisher module of the disclosed technology to determineprime doses from therapeutic doses may include additional or alternativemethods for dose distinguishing. In one example, a method to determineif a dispensed dose is prime or not includes sensing if the pen device10 is in contact with the body at the time of injection. This can bedone in any of several ways. In one non-limiting example, the pen device10 can include a pressure sensor coupled to the needle assembly or tipor end of the body of the pen device 10 to determine if a force has beenapplied at the needle assembly or tip of the device (as when injecting).In one non-limiting example, the pen device 10 can include a capacitivesensor fitted near the end of the device which would sense proximity tothe body. In either of these exemplary cases, sensing pressure orproximity would result in the dose being considered therapeutic and notprime.

The dose classification method to determine prime doses versus therapydoses can include detecting the speed of doses being delivered. Forexample, it is possible that prime doses are delivered at a faster ratethan non-prime doses. The encoder mechanism of the pen device 10 can beconfigured to record the speed of the dose, e.g., in which the speeddata is transferred to the companion device 5 for processing. The speedmay then be compared to a predetermined dose rate threshold to determineif the dose is prime or not. For example, the encoder mechanism candetect the speed, where the threshold will depend on the gear ratio, andthe encoder counts per revolution and/or other factors. It may bedetermined that doses resulting in average dose speeds over a pulse persecond threshold are prime doses. This dose rate threshold could bedetermined by asking users to deliver a series of both prime and therapydoses and comparing the average dose speed of each. If there is littleoverlap in the dose speed ranges of each type of dose then dose speed isa good indicator of type of dose. In some implementations, for example,the dose distinguisher module can utilize the detected dose speed inaddition to the dose dispensing groupings within the predeterminedamount of time proximity to identify the therapy dose from a prime dose.In some implementations, for example, the dose distinguisher module canutilize the detected dose speed without consideration of the sequence ofdoses in a dose dispensing grouping.

In some implementations, the dose classification method to determineprime doses versus therapy doses can involve the pen device 10 includinga shroud assembly around all or part of the needle of the needleassembly and a sensor in the shroud assembly. In implementations, whenthe needle is injected into a patient, the shroud would contact the skinand slide back, triggering the sensor to detect and indicate an actualtherapy dose. If the shroud does not move back, it would indicate thepen was being held in the air and the dose would be considered a prime.Alternatively, instead of the shroud, the sensor can be structured in anassembly including a small button or lever that contacts the skin andfunctions similarly.

In some implementations, the dose classification method to determineprime doses versus therapy doses can involve the pen device 10 includingan internal accelerometer, gyroscope, or other rate sensor to detectmovement data of the pen device 10, which is transferred to thecompanion device 5 to analyze the movement data. For example, if the pen10 senses an inward motion before the dose is dispensed and an outwardmotion after the dose is dispensed, the companion device 5 wouldindicate that the pen 10 had been injected into a patient and therebyidentify the dispensed dose as a therapy dose; whereas if these motionswere absent, it would indicate that the pen 10 had been held in the air.

In some embodiments of the dose distinguishing module, for example, themodule can include a ‘voting’ method to determine if a dose is a primedose. In an illustrative example of the voting method, the dosedistinguishing module can implement multiple embodiments of the doseclassification method in parallel for a particular dosing sequence,e.g., such as the exemplary dose grouping process (e.g., identifying thelast dispensed dose in a sequence of doses dispensed in a predeterminedtime proximity as the therapy dose), the exemplary dose speed detectionprocess, the exemplary movement data detection process, etc. If after aparticular dosing or dosing sequence, a certain majority of theexemplary methods for dose distinguishing indicated that the dispenseddose is a prime dose, and a minority method indicated it is not, thenthe voting method would determine that in this case the dose would beidentified as a prime dose.

Interaction with External Devices

In some embodiments, for example, the pen device 10 or the companiondevice 5 can receive health related information such as blood glucoseinformation from an external device (e.g., such as a blood glucose meteror continuous glucose monitor) for use in the dosing calculations. Thisinformation could be manually entered, downloaded manually orautomatically from a central health information repository, e.g., suchas Apple “Healthkit” or Google “Fit”, or received wirelessly onto thecompanion device 5. In addition to being used in the dosingcalculations, for example, the most recent health related data (e.g.,blood glucose information) could be displayed on the companion device 5,or the pen device 10 in certain embodiments. If recent blood glucoseinformation was available from one of these sources, it couldautomatically be entered into the dose calculation device. In theseexamples, ‘recent’ for the purposes of blood glucose measurement canmean any time period in a range of 0 to 20 minutes old.

In some embodiments, for example, the pen device 10 or the companiondevice 5 can receive health related information such as carbohydrateconsumption information that may be entered manually by the user, orreceived from either a secondary application on the companion device 5or a central health repository, e.g., such as Apple “Healthkit” orGoogle “Fit”, received wirelessly onto the companion device 5. Inaddition to being used in the dosing calculations, the most recentcarbohydrate information can, in some implementations, be displayed onthe companion device 5, or the pen device 10 in certain embodiments. Insome implementations, if recent carbohydrate information was availablefrom one of these sources, it would automatically be entered into thedose calculation device. In these examples, ‘recent’ can mean any timeperiod in a range of 0 to 20 minutes old.

In various embodiments, at the time that the dose is to be calculated,the companion device 5 can verify that it has the most up to date doseinformation by communicating with the pen device 10. In someimplementations, for example, if communication with the pen isunavailable, then the automated dose calculation features would notfunction or would only function after a user acknowledged a warning. Thesystem can include such a safety mechanism to ensure that additionalmedicament (e.g., insulin) has not been given that has not been includedin the dose calculation. In some embodiments, for example, othermechanisms can be included to know if the pen device 10 had recentlycommunicated with the companion device 5, e.g., such as the dosecalculation being shown in different colors (e.g., red for no recentcommunication, and green for recent communication), the “Insulin onBoard” (JOB) feature being shown in different colors (e.g., red for norecent communication, and green for recent communication), and/or acommunication icon being present or not or changing color to indicatecurrent communication or not. In some embodiments, for example, amechanism for communication of information regarding doses and IOB couldbe through haptic feedback where a single vibration or series ofvibrations over time (e.g., such as via a vibration motor) couldindicate the status to the user. In these examples, ‘recent’ can meanany time period in a range of 0 seconds to 2 hours.

Communication Checking

The system includes communication checking between the pen device 10 andthe companion device 5, which can provide protections from inappropriatedosing by the patient. For example, in some embodiments, the softwareapplication of the companion device 5 can prompt or ask the user if theywould like to enter doses manually. If the user answers “yes”, then thedose calculator would be allowed to function although a message to theuser would warn them that dose recommendations may be dangerous if theydo not track all of their doses. If the user answers “no”, then the dosecalculator will remain disabled until communication with a pen isre-established.

Pairing of Dosing Events Between the Pen and the Companion Device

In some embodiments, once the dose calculator has been used and a dosehas been delivered, these events can be “paired” as having been related,e.g., via the software application on the companion device 5. Becausethe dose could be delivered manually by the pen device 10 (and notcommanded by the companion device 5), it may be necessary or desired todetermine if the dose calculator was used to determine the size of thisspecific dose. The time between events may be used to “pair” theseevents. A window of time that the two events happen within could beused. For example, if a dose happens within ±1, 2, 5, or 10 minutes of adose calculator use, then those events could be paired as related.

Alerts and Safety Features

In some implementations, for example, the companion device 5 transmitsthe calculated dose to the pen device 10 for delivery. In someimplementations, for example, the companion device 5 transmits therecommended dose to the pen device 10 which then provides a mechanicallock-out which prevents the user from delivering more medicament thanwas calculated as a recommended dose. In some implementations, forexample, the software application of the companion device 5 provides aprocess to override the dose lock out feature on to give a larger doseif desired.

In some embodiments, for example, the companion device 5 and/or the pendevice 10 is provided with a method to warn the user if a bolus has beenrecently taken. This is a safeguard against accidentally double dosingfor a meal or taking long acting insulin twice in a day. This alarmcould be active if a second dose is initiated within a predefined periodof time after the previous dose. If the alarm became active, it could besignaled to the user through an audio, visual, and/or tactile(vibratory) method. In some embodiments, for example, the companiondevice 5 and/or the pen device 10 can warn the user of a missed dose. Amissed dose can be identified if a dose has not been given within acertain period of time after a specific time of day or after an averagetime of bolus. For example, with long acting insulins (e.g., Lantus®)the injections are usually given once a day at a specific time of day.The companion device 5 and/or the pen device 10 could average the timeof the injections given on a daily basis and then give a missed dosealarm if no dose is sensed within predetermined or user settable amountof time after that average time, e.g., 2 hours.

In some embodiments, the companion device 5 and/or the pen device 10 canprovide an alert to warn the user of excessive insulin on board (IOB).For example, if the total IOB exceeds a threshold which is user settableto related to the max dose in some way, then the system can generate analarm to inform the patient that the patient may have potentiallyoverdosed. This overdose may be caused by several smaller doses addingto more than the user intends, which is referred to as stacking.

In some embodiments, the companion device 5 and/or the pen device 10 canprovide an overdose alarm. This alarm would be triggered if the doseinjection history and the bolus update when injected predict a potentialfor harm due to excess medicament in the patient. For example, the alarmcould be triggered of successive doses of similar size are detectedbecause that is an indicator of double dosing. The system could providethe alarm if a dose much larger than is recommended is taken. Forexample, a much larger dose could be either a ratio (e.g., more thandouble) or a fixed amount greater (e.g., more than 2 units greater, or acombination where fixed differences are used at the low end (perhapsunder 5 units or so) and ratios are used above that.

The disclosed systems include a maximum dose setting feature. Typically,the user (patient or health care provider) sets a maximum dose in thesettings of the software application resident on the companion device 5and the user is either prevented from delivery a dose above that orwarned before they do. Alternatively, in some examples, a dynamicmaximum dose alarm could be used by the system. This feature woulddetermine a maximum dose based on the patient's history over the lastperiod of time, e.g., perhaps week, month, quarter or other time period.By looking at the dose history over that time period, a maximum doselevel can be set multiple ways. In one example, the maximum dose levelcan be set by taking the highest dose in the period, e.g., the averageof the 3, 5, 10 or more highest doses, the average dose plus some numberof standard deviations of dose, the average highest dose time somefactor (e.g., 1.1, 1.2 etc.) or another method or methods.

With the above exemplary features, the companion device 5 allows thedose history as well as any entered or received dose parametric data tobe reviewed by a physician or the patient or other interested party,e.g., such as an insurance company. This review could be on the displayscreen of the companion device 5, for example, or also prepared in areport for transmission to either a computer, e.g., directly or via thecloud. This transmission could occur wirelessly or through a wiredinterface. Wireless transmission would include uploading to cloud basedservers, email to a selected address, fax to a selected fax number oreven being sent directly to a printer possibly through a service such asAirprint. The report could be formatted several ways including but notlimited to .PDF, .CSV or .JSON file formats.

In various embodiments for hospital, clinical, or physician care use,for example, the pen device 10 and/or the companion device 5 can log andverify doses to a patient. This can be used, for example, to cross checka physician order to a specific patient. The order could be enteredelectronically by the physician, and the companion device 5's softwareapplication would use a method to verify the patient identity (e.g.,barcode scanner, facial recognition, RFID, or other electronic means),the pen could then be unlocked for a given period of time to allow themedicament to be injected. If the dose was not correctly administered(the wrong amount of medicament doses) then, in some implementations, analarm would be presented on the application and sent to the physician.

As discussed above, the companion device 5 to which and/or from whichinformation can be transmitted can include, for example, a stand-alonemobile electronic device, or a multi-application device such as asmartphone, a smart watch, a tablet, a laptop, or a non-mobileelectronic device such as a desktop, television, or devices such as aQualcomm 2Net hub or could also be the cloud (internet-based servers).In some embodiments, for example, the patient wears a wearable companiondevice that can provide pertinent information such as insulin on board,blood glucose, or a display of continuous glucose monitoring. Thiswearable device can be a device dedicated to the pen device 10, or itcan be a multi-application device such as a smartwatch or Fitbit-typedevice, or other. In some implementations, the wearable device may bethe only companion device associated with the pen device, and in otherimplementations, the wearable device is a second companion device thatprovides a more limited interaction with the user, e.g., providing bloodglucose data and indicating dose time. The wearable companion device canbe designed to attach to the user in any configuration, for example onthe wrist as a watch-type device, as a patch, or as a clip-on toclothing. The transmission can occur through any wireless protocol, forexample Bluetooth, Bluetooth low energy, WiFi, ZigBee or any otherappropriate wireless protocol.

In addition to the dose information uploaded from the pen device 10,additional dose information could be entered into the companion device 5manually. This can assist in facilitating dose tracking from devicesother than the pen device 10, or when the pen device 10 is notcommunicating (e.g., dead battery, broken processor) or when the pendevice 10 is out of range. In the exemplary case where the companiondevice 5 is in the cloud, a web based portal could be provided to allowentry of information.

This dose information can be displayed to the patient, physician orother interested party. This display can be on the display screen of thecompanion device 5 or through generation and transmission of a report.The transmission of the report could be email, or direct transfer to thecloud, or direct printing or any other method of communicating theinformation from the companion device 5 to a method of display to aperson. In order to transmit the information, a contact list on thecompanion device 5 may be used to select a person, address or otherdestination for the transmitted information to be sent to.

In some implementations, for example, the information that the patientor health care provider can view, or transmit, may include any pertinentdata, e.g., such as typical therapy analytics. In addition, it maycontain new metrics such as insulin modal day. This graph shows averageblood glucose data for each hour of the day. In some embodiments, thisis determined by averaging and reporting all blood glucose measurementstaken in the report period between two time periods (e.g., typically onehour apart). For insulin the total amount of insulin given within thereport period (e.g., typically 7 days to 90 days) between the two timesare added and divided by the number of days in the period. This producesa graph of the average insulin delivered through each hour of the day.By adding the measurement for each hour of the day the result would bethe total average insulin delivered each day.

In some implementations, for example, another metric that is displayedon the screen or report is dose histogram. This display may beconfigured as a typical histogram showing how many doses of each sizewere delivered. Typically, for example, this histogram would be dividedinto multiple buckets (e.g., 10 buckets but more or less would bepossible). The graph allows the patient or health care provider to get avisual indication of the size of the doses taken in total. Thisindication can help determine if the patient is on fixed dose therapy,correctly carbohydrate counting, etc. and can guide the health care teamto help the patient in the correct way.

Dose Recommendation

The pen device 10 and companion device 5 may also be used to generatedose recommendations for the patient, e.g., based at least in part onthe produced a dose output generated by the dose calculator. In diabetesspecifically, for example, the dose the patient is going to take iscommonly based on carbohydrates to be eaten, current blood sugar, andcurrent insulin on board the pen device 10. Any or all of thisinformation could be entered into the companion device 5 such that thecompanion device 5 can generate a dose recommendation that the usercould then take (i.e., inject) using the pen device 10. In someimplementations, for example, the dose recommendation would betransmitted to the pen device 10 for the user to inject, and in someexamples may display on a display screen of the pen 10. In someimplementations, for example, the patient must manually receive the doserecommendation from the companion device 5 (e.g., view the doserecommendation on a display screen of the companion device 5) and enterit into the pen (e.g., set the recommended dose using the dose settingmechanism of the pen device 10).

Because dose recommendations are based, in part, on current insulin onboard, if the companion device 5 is unaware of recent doses, then therecommendation may not be correct or appropriate. For that reason, insome implementations, the dose calculator will not offer or provide adose recommendation unless communications with the pen device 10 haverecently occurred. This can ensure that the insulin on board (JOB)information is up to date. Once the dose recommendation has beengenerated, for example, it can either be entered into the pen device 10and dosed, or it could be viewed remotely by a third party. The dosecould then be remotely approved by the third party. The approval couldconstitute a message of approval, allowing the companion device 5 todisplay the dose suggestion, allowing the dose suggestion to betransmitted to the pen device 10 or unlocking the pen device 10 to allowinjection of the dose.

Temperature Sensor

In some embodiments, for example, the pen device 10 includes atemperature sensor to detect temperature of or near medicine cartridge,in which the detected temperature data is reported to the companiondevice 5 to record current and past temperatures associated with the pendevice 10. For example, the temperature data can be used by thecompanion device 5 to determine if the medicament has exceeded acritical temperature threshold. If a temperature limit is exceed, thecompanion device 5 can produce an alarm (e.g., providing a visual,haptic, or sound) to alert the user. In some implementations, forexample, a temperature time limit can be used in the determination ofthe status of the medicament. For example, the temperature time limitmetric is an integration of the temperature time curve where largernumbers indicate greater exposure to temperature extremes. Thistemperature information can also be used to modify dose calculationsbased on known temperature effects to the medicament.

Medicine Cartridge Retraction Detection

In some embodiments, for example, the pen device 10 can be configured tosense the replacement of a cartridge by detecting the retraction of thelead screw. For example, when the medicine cartridge is replaced byanother medicine cartridge, the lead screw will be retracted which wouldcause the encoder to spin (and record movement). If the encoder were toindicate travel in an opposing direction (e.g., negative direction oraway from dose) and/or of an indicative value of greater than apredetermined threshold number of units (e.g., 1, 5, 10 or other, as inthe case of insulin) or other metric with other drug, then this data canbe processed by the system (e.g., the data processing unit of thecompanion device 5 or within the pen 10 itself) to determine that themedicine cartridge has been replaced. In the case of a replacedcartridge, for example, active temperature alerts would be cleared,e.g., because any drug like insulin that was suspect has now beenreplaced. Also, for example, any modifications to the dose calculatoralgorithm based on known temperature effects of the insulin could alsobe cleared.

Bonding/Pairing of the Pen and the Companion Device

In some implementations of the disclosed intelligent medicineadministering system, the pen device 10 can be ‘bonded’ or ‘paired’ tothe companion device 5 and ‘unbonded’ or ‘unpaired’ to the companiondevice 5 based on the following security communication methods. Forexample, the bonding of a particular pen device belonging to the user toa particular companion device of the user (e.g., the user's smartphonedevice, tablet, etc.) may need to be reset or cleared so that that theparticular pen may be bonded to a new companion device of the user orother (e.g., such as a new smartphone, tablet, etc. of the user). Thebonding security feature can include a security code that the userenters on the companion device 5 via the user interface of the softwareapplication after the pen device 10 is detected by the companion device10 as a pen device to be bonded. The unbonding security feature caninclude a program stored in the memory of the pen device 10 and/or inthe cloud for providing to a new companion device, in which the programis created by the user operating a particular pattern of detectableimplementation events performed on the pen device 10. For example, theprogram can unlock the pen-companion device bonding between the pendevice 10 and the initial companion device 5 (e.g., which may have beenlost, damaged, or replaced by the user) when the user implements thepattern, e.g., and therefore allow the pen device 10 to be bonded toanother companion device of the user. For example, the program couldinclude a pattern of dosing events (e.g., without a cartridge to avoidwasting medicine), e.g., such as 2-5-2-7: dispensing of 2 (empty) units,5 (empty) units, 2 (empty) units, and then 7 (empty) units, or any otherpattern. For example, the program could include a pattern of settingevents, e.g., such as by turning the jack screw in and out in a certainpattern (e.g., turn in more than two units, turn out more than twounits, etc.), which could include repeating this pattern at least 1, 2or 3 or more times all within a fixed period of time (e.g., 1, 2, 5 ormore seconds). Implementation of the user-set pattern would enable thepen device 10 to be set back in a mode where it may be bonded or pairedto a new companion device 5.

In some implementations, for example, the companion device 5 can includehints or reminders of the user-set program in cases where the userforgets the pattern he/she set. Such information can be encrypted andstored in memory on the companion device 5, or in the cloud in anaccount, or sent to the user via electronic communication (e.g., such asa text, email, etc.). In initial set-up of the pattern, the companiondevice can display a summary of the pattern for approval for the user,e.g., to ensure that the user is aware of the pattern in the programcapable of unbonding the pen-companion bonding relationship.

FIG. 3A shows a flow chart diagram of an exemplary method of initialbonding of the user's pen device 10 to the user's initial companiondevice 5 and unbonding of the pen device 10 from the initial companiondevice 5 to allow for subsequent bonding of the pen device 10 to theuser's new or other companion device 5. A method 310 can be implementedby the devices to bond the pen device 10 to the initial companion device5. The method 310 includes a process 311 for the user to perform a dosesetting and/or dispensing operation (e.g., dial a dose) with the pendevice 10. The method 310 includes a process 312 for the initialcompanion device 5 to communicatively connect with the pen device 10.The method 310 includes a process 313 for the initial companion device 5to initiate a device bonding sequence to bond the pen device 10 to thecompanion device 5. The method 310 includes a process 314 to prompt theuser, e.g., via the display of the initial companion device 5, to entera bond code (e.g., such as a default code in the instructions of the pendevice 10, or a code sent independently to the user for entry) on theuser interface of the software application of the initial companiondevice 5. In some implementations, for example, the bond code caninclude a numeric, alphabetic, symbolic, or other text based code. Themethod 310 includes a process 315 to provide encryption keys (e.g., BLEencryption keys using a Bluetooth communication protocol) to the pendevice 10 and the software application on the initial companion device5, and thereby bonds the devices. The method 310 includes a process to315 b to conclude the bonding method 310.

The pen device 10 may remain bonded to the initial companion device 5indefinitely, e.g., for the entire lifetime of the devices. If the pendevice 10 is lost or disposed of, for example, then the user may replacethe pen device 10 with a new pen device 10, in which the new pen device10 can be bonded to the initial companion device 5 by implementation ofthe method 310. If the initial companion device 5 is no longeraccessible to the user, e.g., due to being lost, stolen, damaged, orreplaced, the pen device 10 can undergo a method 320 to unbond the pendevice 10 from the inaccessible initial companion device 5.

The method 320 includes a process 321 to initiate prompt the user, e.g.,via a display of the new/other companion device 5, to clear the bondingof the pen device 10 from the initial companion device 5. For example,the process 321 can include providing instructions, e.g., on the displayof the new/other companion device 5, for the user to perform two or moredispensing operations of the injection pen device in a predeterminedtime frame. In some implementations of the process 321, for example, theprocess 321 includes initiating, at the new/other companion device 5, acount of the predetermined time frame, e.g., which may be displayed tothe user. As the user performs the two or more dispensing operations,e.g., dialing and dispensing two or more (empty) doses using the pendevice 10, a process 322 of the method 320 is implemented to receive, asthe new/other companion device 5, such pattern data associated with theoperations of the pen device 10 performed by the user over thepredetermined time frame. The method includes a process 323, at the pendevice 10, to clear the bond code and associated encryption keysassociated with the initial companion device 5, and thereby unbonds thepen device from the initial companion device 5. The pen device 10 andthe new/other companion device 5 can then implement the method 310 tobond the devices.

For example, in some implementations of the method 320 of unbonding aninjection pen device from a bonded mobile communication device, themethod 320 can include displaying instructions to a user of theinjection pen device that has been communicatively bonded to the initialcompanion device 5 (e.g., a first mobile communication device), via adisplay screen of the new/other companion device (e.g., second mobilecommunication device), to perform two or more operations of theinjection pen device in a predetermined time frame; initiating, at thesecond mobile communication device, a count of the predetermined timeframe; receiving, at the second mobile communication device, patterndata associated with the operations of the injection pen deviceperformed by the user over the predetermined time frame; andtransmitting, from the second mobile communication device to theinjection pen device, a clearing code to cause the injection pen deviceto clear encryption keys associated with first mobile communicationdevice. In some implementations, for example, the method 320 can includestoring the pattern data in a database including a user account of theuser. In some implementations, for example, the second mobilecommunication device can then initiate a bonding sequence tocommunicatively bond the second mobile communication device with theinjection pen device, e.g., to implement the method 310. For example, insome implementations of the method 310, the method can include promptingthe user, at the display screen of the second mobile communicationdevice, to enter a bond code into the second mobile communicationdevice; receiving, at the second mobile communication device, theuser-entered bond code; and providing, at the second mobilecommunication device, encryption keys to the injection pen device andthe second mobile communication device. For example, the bond codeincludes a text based code including numeric text, alphabetic text,symbolic text, or a combination thereof.

FIG. 3B shows a diagram of an exemplary method of unbonding a pen devicefrom a companion device. The method includes a process 352 to provideinstructions to a user of the injection pen device that has beencommunicatively bonded to a first mobile communication device to performan operation sequence including two or more operations of the injectionpen device in a predetermined time frame. The method includes a process354 to initiate, e.g., by a processing unit of the injection pen device,a count of the predetermined time frame once a dose setting mechanism ofthe injection pen device is set at or greater than a first level. Themethod includes a process 356 to detect, e.g., by a sensor of theinjection pen device, operations of the dose setting and a dosedispensing mechanism of the injection pen device. The method includes aprocess 358 to clear encryption keys stored in the processing unit ofthe injection pen device associated with the first mobile communicationdevice when the operation sequence is detected within the predeterminedtime.

Implementations of the method shown in FIG. 3B can optionally includethe following exemplary features. For example, the instructions caninclude (i) operating a dose setting mechanism of the injection pendevice to the first level or greater than the first level, (ii)operating the dose setting mechanism to a second level less than thefirst level, (iii) operating the dose setting mechanism to a third levelgreater than the second level, (iv) operating the dose setting mechanismto a fourth level less than the third level, and (v) operating a dosedispensing mechanism of the injection pen. Similarly, for example, theinstructions can include (i) operating a dose setting mechanism of theinjection pen device to the first level or less than the first level,(ii) operating the dose setting mechanism to a second level greater thanthe first level, (iii) operating the dose setting mechanism to a thirdlevel less than the second level, (iv) operating the dose settingmechanism to a fourth level greater than the third level, and (v)operating a dose dispensing mechanism of the injection pen. In someimplementations of the method, for example, the process to provide theinstructions can include displaying the instructions to the user on adisplay screen of a second mobile communication device to perform thetwo or more operations of the injection pen device. In someimplementations of the method, for example, the method can furtherinclude a process to bond the injection pen device to the second mobiledevice by the following: initiating, by a second mobile communicationdevice, a bonding sequence to communicatively bond the second mobilecommunication device with the injection pen device; prompting the user,at the display screen of the second mobile communication device, toenter a bond code into the second mobile communication device;receiving, at the second mobile communication device, the user-enteredbond code; and providing, at the second mobile communication device,encryption keys to the injection pen device and the second mobilecommunication device.

Find My Pen

In some implementations, for example, the pen device 10 and companiondevice 5 may be in communication at various intervals from many times asecond to once every several minutes or several hours. In instanceswhere the companion device 5 includes a GPS system, the location of thecompanion device 5 can be determined, and therefore the pen can be knownat each communication. For example, if the location of eachcommunication or the last communication were logged and then thecommunication ceased, the system would know approximately wherecommunication ceased. This can be extremely helpful in situations wherethe user loses his/her pen by leaving it behind somewhere, for example.The software application of the companion device 5 can then provide GPScoordinates, or a location on a map, or directions, or other informationshowing the user where he/she had left the pen device 10.

Exemplary User Interface and User Features

FIGS. 2A-2F show display screens of an exemplary user interface of asoftware application resident on the companion device of the disclosedintelligent medicine administering system. FIG. 2A shows an example of auser interface display for the exemplary dose calculator. For example,the exemplary dose calculator user interface can include informationabout the medicine loaded in the pen device 10 (e.g., active insulin)and/or dose information (e.g., including the time of the last dose,amount of the last dose, etc.). The exemplary dose calculator userinterface can include an interactive region of the display that allowsthe patient to enter data about their recent analyte levels (e.g., bloodglucose levels), carbohydrates intake, calories intake, or other fooddata intake or activity data. The exemplary dose calculator userinterface can include a recommended dose (e.g., a certain amount of themedicine in the pen device 10) displayed on the screen based on theprocessed data, e.g., including the dose data received from the pendevice 10 and the inputted data from the patient in the interactiveregion. In some implementations, for example, the exemplary dosecalculator user interface can include an interactive button to log thedose to allow the patient to manually log a dose. For example, the logbutton feature could be used to manually log a dose in situations wherethe pen device 10 was not used. This could be that the patient haschosen to take a dose from another mechanism, e.g., such as a syringe,or that the battery of the pen device 10 has depleted and doses are nolonger being logged.

FIG. 2B shows an example of a user interface display for an exemplarydose history record, which allows the patient to review their dosedispensing history for a particular medicine. For example, the exemplarydose history user interface can include information about the recentdoses logged over a certain period of time, e.g., such as “today”, orover selected days, weeks, or other time frame.

FIG. 2C shows an example of a user interface display for an exemplarytherapy report, which can be available to patients and made available tohealthcare providers. For example, the exemplary therapy report canallow healthcare providers to review administered therapies and makesuggestions accordingly. The exemplary therapy report user interface caninclude an text and graphics presenting information on average doses ofa particular medicine over a user-selected time period, doses per day,total daily doses, average analyte levels of the patient, dosecalculator usage, the amount the average dose differs from the averagerecommended dose and other data.

FIG. 2D shows an example of a user interface display for exemplaryalerts. For example, the exemplary temperature alerts provides the userswith urgent and/or actionable information regarding monitored parametersof the pen device 10 and/or the patient's management of the medicinecontained in the pen device 10. In the example illustrated in FIG. 2D, ahigh temperature alert for the medicine in the pen device 10 is signaledon the display screen of the software application user interface, e.g.,in which the high temperature alert may indicate that the medicine couldhave lost its effectiveness.

FIG. 2E shows an example of a user interface display for exemplaryremote notifications. For example, the exemplary notifications can beprovided via text messages, email, or other types of communications thatprovide certain patient data to parents or caregivers to allow them tomonitor the patient's therapy management remotely.

FIG. 2F shows an example of a user interface display for exemplary userverification or override of the determined dose type by the dosedistinguisher module. For example, after a dose is displayed in thehistory screen (e.g., manually entered or automatically communicated bythe pen 10), the user can select a displayed individual dispensed doseby pressing on its row entry in the table of the history interface.After being selected, an exemplary GUI screen (such as that shown inFIG. 2F) with the dose/prime selection pops up as an overlay allowingthe user to then select which type of dose that entry should be. Forexample, if the entry was changed from the original determined type, thehistory display and record are updated with the new user selection.

In some implementations, for example, the system may allow bothautomatic as well as manual logging of doses. In such cases, the systemcan include a dose duplication checking feature included in the softwareapplication of the companion device 5 to check for duplicate manual andautomatically transferred dose data inputs to the companion device 5. Inan example, the user could manually log a dose which has beenautomatically logged due to misunderstanding or other factors. Forexample, if the system sees multiple doses of the same size or similarsize logged by different methods (manually and automatically) within asmall period of time (e.g., such as 1 to 5 or 10 minutes, or other settime frame), then the system could assume they are duplicates andautomatically delete one of the doses.

In some embodiments, the pen device 10 can include a light to emit lightfrom the pen device 10. The emitted light can be automatically producedby the pen device 10 based on a received control signal from thecompanion device 5 (or, for example, from a data processing unit of thepen device 10) to provide a reminder to the user that he/she has or hasnot taken the medication based on a schedule or dose tracking program(e.g., such as insulin). The emitted light may also serve as anindicator of active insulin on board. For example, if the user's activeinsulin time is set to 5 hours, then the light could be lit for 5 hoursafter each dose. If the light was out, the user would know immediatelythat they had not dosed in some time and had no active insulin. If thelight was lit, they would know that they had active insulin and musttake it into account during any dose calculations being made. In someembodiments, for example, the signal could be through haptic feedbackwhere a single vibration or series of vibrations over time possibly viavibratory motor and could indicate IOB, dosing, alarms, or a combinationthereof.

Exemplary Embodiments of the Pen Device 10

FIGS. 4 and 5 show schematic illustrations of exemplary embodiments ofthe pen device 10. Turning now to FIGS. 4 and 5, the overall operationis that a mechanism is provided to force a displacement of a pistonwhich resides within a medicament vial or cartridge 85. The displacementof the piston of the medicament vial 85 forces a volume of themedicament (that is proportional to the displacement of the piston) outof the vial 85, e.g., allowing it to be injected into a patient. Thevial 85 is held within a medicament housing 25 of the pen device 10. Themedicament housing 25 attaches to a main body housing 15 of the pendevice 10, which includes a dose setting and dispensing mechanism andelectronics unit of the pen device 10. In some embodiments, for example,the medicament housing 25 and the main body housing 15 may be a singularhousing structure. The medicament housing 25 is structured to include achamber to hold and/or encase the medicament vial 85 within the housing25 of the pen device 10. The pen device 10 can also include a detachablepen cap (not shown) to cover an end of the pen device 10 that exposes aneedle assembly (not shown) of the pen device 10 to disburse themedicine out of the pen device 10 when dispensed from the vial 85. Thepen device 10 can include a vial spring 35, which provides a force on ascrew retractor 55 to push the medicament vial 85 into the medicamenthousing 25 to ensure good dose accuracy. The pen device 10 includes adose knob 20 attached to or included as part of the housing 15, wherethe dose knob is coupled to the housing by a non-self-locking thread 60.In some embodiments, for example, an electronics housing 30 may residewithin the dose knob 20, in which the electronics housing 30 containsthe electronics unit of the pen device 10. The dose setting mechanismincludes a dose knob 20. When the dose knob 20 is rotated into or out ofthe housing 15 to adjust the dose, the electronics housing 30 does notturn. However, when translational or axial force is placed to the dosebutton 65 (e.g., in which resides the electronics housing), a catchstructure component is engaged to lock the electronics housing 30 anddose knob 20 together, forcing them to rotate together as the pairtravel back into the housing 15 upon actuation of the dose dispensingmechanism to apply force to the dose knob 20 to cause dispensing of theset dose. The rotation of the dose knob 20, e.g., which can be via theelectronics housing 30, rotates a shaft 50 (e.g., which can beconfigured as a bi-directional clutch shaft). The shaft 50 in turnrotates a dose screw 70 which rides within a nut 75 which is fixed tothe housing 15. This rotation causes the dose screw 70 to extend out ofthe housing 15 causing an injection of medicament. In some embodiments,for example, the dose dispensing mechanism can include afriction-causing structure 80, e.g., which can be coupled to theexemplary bi-directional clutch shaft 50 to present a frictionoussurface (i.e., a surface that provides friction) to make contact withthe nut 75 or housing body 15 or other internal structure of the dosedispensing mechanism, which acts from the bi-directional clutch shaft 50to the housing 15 or nut 75 to prevent rotation of the shaft 50 whilethe dose setting mechanism is being adjusted via turning of the doseknob 20, but also allowing the friction to be overcome during the dosedispensing operation. In addition, by overcoming friction in theopposite direction the dose screw 70 may be driven back into the housing15 and prepared for a new cartridge of medicament to be loaded. In someembodiments, for example, the pen device 10 includes a screw retractorcomponent 55 that is axially fixed to the housing but rotationally free.The screw retractor component 55 is operable to be bent in to “grab” thenon-circular cross section of the dose screw 70 allowing it to berotated relative to the housing 15 and driven back into the housing 15.In some implementations, for example, the components of the pen device10 could be manufactured by injection molding, machining or othersimilar process. In embodiments including the bi-directional clutchshaft, for example, the pen device 10 is capable of allowing retractionof the lead screw, and repeatability of operation of the dose dispensingmechanism.

In some embodiments, the sensor unit of the pen device 10 includes arotational encoder, for example, between the dose knob 20 (e.g., whichcan be coupled to the jack screw) and the housing 15, and in electricalcommunication with the electronics unit contained in the electronicshousing 30. The encoder is included in a sensor unit to determine thequantity of the dose set by the dose setting mechanism, and/or, thequantity of the dose dispensed by the dose dispensing mechanism. In someimplementations, for example, the encoder can be configured in the pendevice 10 to determine the dispensed dose by detecting rotation of thelead screw which is correlated with displacement of the pusher footwhich is correlated with displacement of the receiving plunger in thevial 85, which in turn is correlated with dispensed insulin. In someembodiments, for example, the encoder can include two flat plates withcontacts in between them. The plates are aligned perpendicular to theaxis of the device. For one plate, a contact plate 40 is rotationallyfixed to the jack screw, e.g., which can be via the electronics housing30; and for the other plate, a code wheel 45 is rotationally fixed tothe housing 15. In implementations, for example, when relative motionoccurs between these two plates during dosing, the relative motion ismeasured and transmitted to the data processing and communications unitfor processing, storage and/or transmission to the companion device 5.

In some embodiments of the pen device 10, for example, the dose settingand dispensing mechanism may include a mechanism in which the dose screw70 is comprised of an elongate nut which screws in and out of thehousing to provide dosing. The nut component in the previous describedembodiment (e.g., nut 75) can include a separate screw structure;whereas in this embodiment of the dose screw, the nut component is partof the dose screw including exterior threads and is coupled to thehousing 15. When the exemplary bi-directional clutch shaft 50 providesrotation, it operates on the jack screw, e.g., in which the dosing nutin this case threading it out of the housing.

Exemplary Implementations of Companion Device

In some implementations of the companion device 5, for example, thesoftware application can include data processing algorithms stored asexecutable code in the memory of the data processing unit of thecompanion device 5 and an executable user interface to be provided toassist the user in determining the size of the dose they require. Oneexemplary algorithm includes a dose calculator or suggestion algorithm.Typical inputs to the dose calculator algorithm can include currentblood glucose as well as carbohydrate content that the user intends toeat. For example, these can be inputs can be received on the companiondevice 5 via the user interface by providing up and down arrows or anumeric keypad. A slider could be used to allow the user to quicklyachieve the desired input value. In addition, plus and minus keys (e.g.,or up and down keys) could be provided to fine tune the informationentered on the slider if need be. In addition, dynamic scaling of theslider could be implemented where the historical inputs are used todetermine a likely maximum and minimum range for the slider. Forexample, if the user has entered carbohydrate content from 20 to 80grams, then the slider could use 20 g as the low end and 80 g as theupper end, or it could add some margin for example allowing 20 to 90grams to be entered. In this way, for example, the companion device 5tailors itself to the needs of the patient.

In order to verify the existing bonding or pairing of the pen device 10to the companion device 5 and ensure that the correct pen is bonded orpaired with the device 5 (e.g., smartphone), in some embodiments, thecompanion device 5 could ask the user to dose a particular dose from thepen. The user would then dial in and deliver whatever dose wasrequested. This would provide a level of certainty that both thecompanion device and pen were under control of the user and preventinadvertent pairing.

Because it is desired to know when a cartridge is replaced, it ispossible to interpret the encoder signal to label a cartridgereplacement. In some implementations, for example, the encoder may be afull quadrature encoder which can detect movement in both directions(and differentiate between them). However, detecting a cartridgereplacement is not as easy as detecting rearward motion because therecan be some rearward motion at any time. The data processing unit can beprogrammed to process all rearward motion detected by the exemplary fullquadrature encoder within a time period (e.g., 1 second to 2 minutes) tobe summed, and if the total is over a threshold (e.g., 50 units), thenthe event be labeled a cartridge replacement.

In the companion device 5 a simplified set of timed parameters may beutilized. In one example implementation, for example, four timed periodsare predetermined (e.g., breakfast, lunch, dinner and bedtime). The timeof each event is entered into a screen. Each of the clinical variables(e.g., carbohydrate factor, correction factor, target blood glucose,etc.) can then be entered for each time period. Implementations of thetimed parameters may greatly speed the operations of the system.

FIG. 6A shows a diagram of an exemplary method to classify a dose ofmedicine dispensed from an injection pen. The method includes a process602 to detect one or more doses of medicine dispensed from an injectionpen device and time data associated with the one or more dispensed dosesto generate dose data corresponding to dispensing events. The methodincludes a process 604 to process the dose data corresponding to one ormore dispensing events over a predetermined duration of time to form adose dispensing sequence. The method includes a process 606 to determinea type of dispensing event as a priming event or an injection event forthe dose data in the dose dispensing sequence by assigning a lastdispensing event in the dose dispensing sequence as the injection eventand any previous dispensing events in the dose dispensing sequence asthe priming events.

Implementations of the method shown in FIG. 6A can optionally includethe following exemplary features. For example, in some implementations,the method can further include detecting force signal data applied at adispensing portion of the injection pen device; detecting force timedata associated with the force data; processing the detected forcesignal data and force time data to determine physical contact betweenthe dispensing portion and a body based on a predetermined forcethreshold; comparing the force time data associated with determinedphysical contact to the time data associated with the last dispensingevent; and determining that the type of dispensing event of the lastdispensing event is the injection dose if the force time data associatedwith determined physical contact corresponds to the time data associatedwith the last dispensing event, or determining that the type ofdispensing event of the last dispensing event is a priming event if theforce time data associated with determined physical contact does notcorrespond to the time data associated with the last dispensing event.In some implementations, for example, the method can further includecomparing the amount of the dispensed doses for each of the dispensingevents in the dose dispensing sequence to a predetermined dose quantitythreshold; and determining the type of dispensing event for a dispenseddose having its amount larger than the predetermined dose quantitythreshold and the largest amongst the compared dispensing events as theinjection event.

FIG. 6B shows a diagram of another exemplary method to classify a doseof medicine dispensed from an injection pen. The method includes aprocess 652 to detect one or more doses of medicine dispensed from aninjection pen device and time data associated with the one or moredispensed doses to generate dose data corresponding to dispensingevents, in which the detecting includes sensing a rate at which themedicine is dispensed from the injection pen device. The method includesa process 654 to process the dose data corresponding to one or moredispensing events over a predetermined duration of time to form a dosedispensing sequence. The method includes a process 656 to compare therate of the one or more dispensed doses for each of the dispensingevents in the dose dispensing sequence to a predetermined dispensingrate threshold. The method includes a process 658 to determine a type ofdispensing event as a priming event for a dispensing event in the dosedispensing sequence when the corresponding sensed rate is slower thanthe predetermined dispensing rate threshold, and to determine the typeof dispensing event as an injection event for a dispensing event in thedose dispensing sequence when the corresponding sensed rate is fasterthan the predetermined dispensing rate threshold.

Examples

The following examples are illustrative of several embodiments of thepresent technology. Other exemplary embodiments of the presenttechnology may be presented prior to the following listed examples, orafter the following listed examples.

In one example of the present technology (example 1), a system foradministering a medicine to a patient includes an injection pen deviceand a mobile communication device in wireless communication with theinjection pen. The injection pen device includes a housing including amain body structured to include a chamber to encase a cartridgecontaining medicine when the cartridge is loaded in the chamber, a dosesetting and dispensing mechanism to set and dispense a particular doseof the medicine from the loaded cartridge, the dose setting anddispensing mechanism including a dose knob, a shaft, and a pistonassembly including a plunger, in which the dose knob is rotatable tocause the shaft to move to a position proportional to a set dose of themedicine, and in which the dose knob is translationally moveable tocause the shaft to drive the plunger to push against the cartridge todispense the medicine from the cartridge, a sensor unit to detect adispensed dose based on one or both of positions and movements of thedose setting and dispensing mechanism, in which the dispensed doseincludes an amount of medicine dispensed from the cartridge, and anelectronics unit in communication with the sensor unit, the electronicsunit including a processing unit including a processor and memory toprocess the detected dispensed dose and time data associated with adispensing event to generate dose data, a transmitter to wirelesslytransmit the dose data to a user's device, and a power source to provideelectrical power to the electronics unit. The mobile communicationdevice includes a data processing unit including a processor to processthe dose data and a memory to store or buffer the dose data, a displayto present a user interface to the user, and a wireless communicationsunit to wirelessly receive the dose data from the injection pen device.

Example 2 includes the system as in example 1, in which the medicineincludes insulin, an infertility treatment drug, or a pain treatmentdrug.

Example 3 includes the system as in example 1, in which the time dataincludes a specific time of occurrence of the dispensing event, or arelative time associated with a beginning, a duration, and/or aconclusion of the dispensing event.

Example 4 includes the system as in example 1, in which the housing ofthe injection pen device further includes a detachable cap to cover anend of the injection pen device including a needle assembly to dispensethe medicine received from the cartridge.

Example 5 includes the system as in example 1, in which the plunger ofthe injection pen device is operable to be moved by the shaft such thatthe plunger pushes against a piston of the cartridge to cause the pistonto move a certain distance that is proportional to the set dose of themedicine to dispense the medicine from the cartridge.

Example 6 includes the system as in example 1, in which the shaft of theinjection pen device includes and a bi-directional clutch shaft.

Example 7 includes the system as in example 6, in which the plunger ofthe piston assembly includes a screw component contained within thebi-directional clutch shaft, and the piston assembly includes a nutcomponent fixed to the main body of the housing, in which movement ofthe bi-directional clutch shaft causes the screw component to rotate ascrew within the nut component and extend out of the main body to makecontact against a moveable surface of the piston of the medicinecartridge.

Example 8 includes the system as in example 7, in which thebi-directional clutch shaft of the injection pen device includes africtionous surface in contact with the main body housing or the nutcomponent and capable of preventing rotation of the bi-directionalclutch shaft when the dose knob is being rotated to set the dose.

Example 9 includes the system as in example 1, in which the sensor unitof the injection pen device is operable to detect the set dose based onone or both of positions and movements of the dose setting anddispensing mechanism.

Example 10 includes the system as in example 1, in which the sensor unitand the data processing and communication unit of the injection pendevice are housed in a housing compartment located in the dose knob, inwhich the housing compartment does not move with the rotation of thedose knob when the dose is being set by the dose setting and dispensingmechanism, and the housing compartment does move with the dose knob whenthe dose is being dispensed by the dose setting and dispensingmechanism.

Example 11 includes the system as in example 10, in which the housingcompartment of the injection pen device includes a catch componentoperable to only couple the housing compartment to the dose knob whenthe dose setting and dispensing mechanism is being operated to dispensethe dose.

Example 12 includes the system as in example 1, in which the transmitterof the injection pen device is operable to wirelessly transmit the dosedata to the mobile communication device using a Bluetooth, a WiFi, or aZigBee wireless transmission.

Example 13 includes the system as in example 1, in which the mobilecommunication device includes a smartphone, a tablet, a wearablecomputing device including a smartwatch or smartglasses, a computerincluding a laptop or a desktop computer, or one or more computersnetworked in a communication network through the Internet.

Example 14 includes the system as in example 1, in which the injectionpen further includes a temperature sensor operable to detect temperatureat or near medicine cartridge, the temperature sensor in communicationwith the signal processing unit to receive the detected temperature.

Example 15 includes the system as in example 1, in which the injectionpen device further includes an operation sensor to detect when the dosesetting and dispensing mechanism is being operated.

Example 16 includes the system as in example 1, in which the dosedispensing mechanism is a motorized mechanism.

Example 17 includes the system as in example 1, in which the processingunit of the injection pen device or the mobile communication deviceincludes a software application program product comprising anon-transitory computer-readable storage medium stored in the memory ofthe data processing unit of the mobile communication device and havinginstructions stored thereon and operable to cause the mobilecommunication device to perform operations, including processing one ormore dose data corresponding to one or more dispensing events over apredetermined duration of time to form a dose dispensing sequence; anddetermining a type of dispensing event as a priming event or aninjection event for the one or more dose data in the dose dispensingsequence, in which the determining includes assigning the lastdispensing event in the dose dispensing sequence as the injection eventand any previous dispensing events in the dose dispensing sequence asthe priming events.

Example 18 includes the system as in example 17, in which the injectionpen device further includes a sensor to detect external force signalsapplied to a needle assembly of the injection pen device that indicatecontact of the injection pen device with the user, and in which thesoftware application program product further includes instructions tocause the mobile communication device to perform: processing thedetected external force signals to determine the presence of contact tothe needle assembly with corresponding time information of the lastdispensing event; and determining the type of dispensing event of thelast dispensing event is the injection dose if there was the presence ofcontact detected, or determining the type of dispensing event of thelast dispensing event is the priming event if there was no presence ofcontact detected.

Example 19 includes the system as in example 17, in which the softwareapplication program product further includes instructions to cause themobile communication device to perform: if a single dispensing eventoccurs in the predetermined duration of time, identifying the singledispensing event as a priming event; or comparing the amount of thedispensed doses for each of the dispensing events in the dose dispensingsequence to a predetermined dose quantity threshold, and determining thetype of dispensing event for a dispensed dose having its amount largerthan the predetermined dose quantity threshold and the largest amongstthe compared dispensing events as the injection event.

Example 20 includes the system as in example 17, in which the sensorunit is operable to detect a rate at which the medicine is dispensedfrom the cartridge, and in which the software application programproduct further includes instructions to cause the mobile communicationdevice to perform: comparing the rate of the dispensed doses for each ofthe dispensing events in the dose dispensing sequence to a predetermineddispensing rate threshold, and determining the type of dispensing eventfor a dispensed dose having its detected rate slower than thepredetermined dispensing rate threshold.

Example 21 includes the system as in example 1, in which the dataprocessing unit of the mobile communication device is operable toprocess the dose data to determine information about the user's health,and in which one or both of the injection pen device and the mobilecommunication device include a visual, auditory, or haptic signalingunit to produce an alert based on the processed dose data.

Example 22 includes the system as in example 1, in which the injectionpen device includes a software application program product comprising anon-transitory computer-readable storage medium stored in the memory ofthe processing unit of the injection pen device and having instructionsstored thereon and operable to cause the injection pen device to performoperations to communicatively unbond the injection pen device from afirst mobile communication device of the user to which the injection pendevice is communicatively bonded, including detecting a pattern sequenceof operations of the dose setting and dispensing mechanism in apredetermined time frame, in which the pattern sequence includes settingthe dose setting and dispensing mechanism to or greater than a firstlevel and operating the dose setting and dispensing mechanism todispense a dose; initiating a count of the predetermined time frame whenthe dose setting and dispensing mechanism is set or greater than at aparticular first level; and clearing encryption keys stored in theprocessing unit of the injection pen device associated with the firstmobile communication device when the pattern sequence is detected in thepredetermined time.

In one example of the present technology (example 23), a method toclassify a dose of medicine dispensed from an injection pen includesdetecting one or more doses of medicine dispensed from an injection pendevice and time data associated with the one or more dispensed doses togenerate dose data corresponding to dispensing events; processing thedose data corresponding to one or more dispensing events over apredetermined duration of time to form a dose dispensing sequence; anddetermining a type of dispensing event as a priming event or aninjection event for the dose data in the dose dispensing sequence byassigning a last dispensing event in the dose dispensing sequence as theinjection event and any previous dispensing events in the dosedispensing sequence as the priming events.

Example 24 includes the method as in example 23, further includingdetecting force signal data applied at a dispensing portion of theinjection pen device; detecting force time data associated with theforce data; processing the detected force signal data and force timedata to determine physical contact between the dispensing portion and abody based on a predetermined force threshold; comparing the force timedata associated with determined physical contact to the time dataassociated with the last dispensing event; and determining that the typeof dispensing event of the last dispensing event is the injection doseif the force time data associated with determined physical contactcorresponds to the time data associated with the last dispensing event,or determining that the type of dispensing event of the last dispensingevent is a priming event if the force time data associated withdetermined physical contact does not correspond to the time dataassociated with the last dispensing event.

Example 25 includes the method as in example 23, further includingcomparing the amount of the dispensed doses for each of the dispensingevents in the dose dispensing sequence to a predetermined dose quantitythreshold; and determining the type of dispensing event for a dispenseddose having its amount larger than the predetermined dose quantitythreshold and the largest amongst the compared dispensing events as theinjection event.

In one example of the present technology (example 26), a method toclassify a dose of medicine dispensed from an injection pen includesdetecting one or more doses of medicine dispensed from an injection pendevice and time data associated with the one or more dispensed doses togenerate dose data corresponding to dispensing events, in which thedetecting includes sensing a rate at which the medicine is dispensedfrom the injection pen device; processing the dose data corresponding toone or more dispensing events over a predetermined duration of time toform a dose dispensing sequence; comparing the rate of the one or moredispensed doses for each of the dispensing events in the dose dispensingsequence to a predetermined dispensing rate threshold; and determining atype of dispensing event as a priming event for a dispensing event inthe dose dispensing sequence when the corresponding sensed rate isslower than the predetermined dispensing rate threshold, and determiningthe type of dispensing event as an injection event for a dispensingevent in the dose dispensing sequence when the corresponding sensed rateis faster than the predetermined dispensing rate threshold.

In one example of the present technology (example 27), a method ofunbonding an injection pen device from a mobile communication deviceincludes providing instructions to a user of the injection pen devicethat has been communicatively bonded to a first mobile communicationdevice to perform an operation sequence including two or more operationsof the injection pen device in a predetermined time frame; initiating,by a processing unit of the injection pen device, a count of thepredetermined time frame once a dose setting mechanism of the injectionpen device is set at or greater than a first level; detecting, by theinjection pen device, operations of the dose setting and a dosedispensing mechanism of the injection pen device; and clearingencryption keys stored in the processing unit of the injection pendevice associated with the first mobile communication device when theoperation sequence is detected within the predetermined time.

Example 28 includes the method as in example 27, in which theinstructions include operating a dose setting mechanism of the injectionpen device to the first level or greater than the first level, operatingthe dose setting mechanism to a second level less than the first level,operating the dose setting mechanism to a third level greater than thesecond level, operating the dose setting mechanism to a fourth levelless than the third level, and operating a dose dispensing mechanism ofthe injection pen.

Example 29 includes the method as in example 27, in which the providinginstructions includes displaying the instructions to the user on adisplay screen of a second mobile communication device to perform thetwo or more operations of the injection pen device.

Example 30 includes the method as in example 27, further includinginitiating, by a second mobile communication device, a bonding sequenceto communicatively bond the second mobile communication device with theinjection pen device; prompting the user, at the display screen of thesecond mobile communication device, to enter a bond code into the secondmobile communication device; receiving, at the second mobilecommunication device, the user-entered bond code; and providing, at thesecond mobile communication device, encryption keys to the injection pendevice and the second mobile communication device.

Implementations of the subject matter and the functional operationsdescribed in this patent document can be implemented in various systems,digital electronic circuitry, or in computer software, firmware, orhardware, including the structures disclosed in this specification andtheir structural equivalents, or in combinations of one or more of them.Implementations of the subject matter described in this specificationcan be implemented as one or more computer program products, i.e., oneor more modules of computer program instructions encoded on a tangibleand non-transitory computer readable medium for execution by, or tocontrol the operation of, data processing apparatus. The computerreadable medium can be a machine-readable storage device, amachine-readable storage substrate, a memory device, a composition ofmatter effecting a machine-readable propagated signal, or a combinationof one or more of them. The term “data processing apparatus” encompassesall apparatus, devices, and machines for processing data, including byway of example a programmable processor, a computer, or multipleprocessors or computers. The apparatus can include, in addition tohardware, code that creates an execution environment for the computerprogram in question, e.g., code that constitutes processor firmware, aprotocol stack, a database management system, an operating system, or acombination of one or more of them.

A computer program (also known as a program, software, softwareapplication, script, or code) can be written in any form of programminglanguage, including compiled or interpreted languages, and it can bedeployed in any form, including as a stand-alone program or as a module,component, subroutine, or other unit suitable for use in a computingenvironment. A computer program does not necessarily correspond to afile in a file system. A program can be stored in a portion of a filethat holds other programs or data (e.g., one or more scripts stored in amarkup language document), in a single file dedicated to the program inquestion, or in multiple coordinated files (e.g., files that store oneor more modules, sub programs, or portions of code). A computer programcan be deployed to be executed on one computer or on multiple computersthat are located at one site or distributed across multiple sites andinterconnected by a communication network.

The processes and logic flows described in this specification can beperformed by one or more programmable processors executing one or morecomputer programs to perform functions by operating on input data andgenerating output. The processes and logic flows can also be performedby, and apparatus can also be implemented as, special purpose logiccircuitry, e.g., an FPGA (field programmable gate array) or an ASIC(application specific integrated circuit).

Processors suitable for the execution of a computer program include, byway of example, both general and special purpose microprocessors, andany one or more processors of any kind of digital computer. Generally, aprocessor will receive instructions and data from a read only memory ora random access memory or both. The essential elements of a computer area processor for performing instructions and one or more memory devicesfor storing instructions and data. Generally, a computer will alsoinclude, or be operatively coupled to receive data from or transfer datato, or both, one or more mass storage devices for storing data, e.g.,magnetic, magneto optical disks, or optical disks. However, a computerneed not have such devices. Computer readable media suitable for storingcomputer program instructions and data include all forms of nonvolatilememory, media and memory devices, including by way of examplesemiconductor memory devices, e.g., EPROM, EEPROM, and flash memorydevices. The processor and the memory can be supplemented by, orincorporated in, special purpose logic circuitry.

It is intended that the specification, together with the drawings, beconsidered exemplary only, where exemplary means an example. As usedherein, the singular forms “a”, “an” and “the” are intended to includethe plural forms as well, unless the context clearly indicatesotherwise. Additionally, the use of “or” is intended to include“and/or”, unless the context clearly indicates otherwise.

While this patent document contains many specifics, these should not beconstrued as limitations on the scope of any invention or of what may beclaimed, but rather as descriptions of features that may be specific toparticular embodiments of particular inventions. Certain features thatare described in this patent document in the context of separateembodiments can also be implemented in combination in a singleembodiment. Conversely, various features that are described in thecontext of a single embodiment can also be implemented in multipleembodiments separately or in any suitable subcombination. Moreover,although features may be described above as acting in certaincombinations and even initially claimed as such, one or more featuresfrom a claimed combination can in some cases be excised from thecombination, and the claimed combination may be directed to asubcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Moreover, the separation of various system components in theembodiments described in this patent document should not be understoodas requiring such separation in all embodiments.

Only a few implementations and examples are described and otherimplementations, enhancements and variations can be made based on whatis described and illustrated in this patent document.

1.-20. (canceled)
 21. An injection device for administering a medicineto a patient, comprising: a housing including a main body structured toinclude a chamber to encase a cartridge containing medicine upon loadingof the cartridge in the chamber; a dose setting and dispensing mechanismto set and dispense a particular dose of the medicine from thecartridge, the dose setting and dispensing mechanism including a doseknob, a shaft, and a plunger, wherein the dose knob is rotatable tocause the shaft to move to a position proportional to a set dose of themedicine, and wherein the dose knob is operable to move translationallyto cause the shaft to drive the plunger to dispense the medicine fromthe cartridge; a sensor to detect a dispensed dose, and an electronicsunit in communication with the sensor unit, the electronics unitincluding a processor and a non-transitory memory to process thedetected dispensed dose and time data associated with a dispensing eventto generate dose data, a power source to provide electrical power to theelectronics unit, and a transmitter operable to wirelessly transmit thedose data to a mobile communication device, the mobile communicationdevice including a software application program product stored in amemory of the mobile communication device and including instructionsoperable to cause the mobile communication device to process one or moreof the dose data corresponding to one or more dispensing events to forma dose dispensing sequence such that the dispensing events of the dosedispensing sequence all occur in temporal proximity of one another thatspan less than a predetermined temporal threshold, and the lastdispensing event in the dose dispensing sequence is identified as theinjection event and one or more of the dispensing events other than thelast dispensing events in the dose dispensing sequence are identified asthe priming events.
 22. The device of claim 21, wherein the injectiondevice further includes a temperature sensor operable to detecttemperature at or near the medicine cartridge, the temperature sensor incommunication with the processor of the injection device to communicatethe detected temperature.
 23. The device of claim 22, wherein thedispensed dose includes an amount of medicine dispensed from thecartridge, and wherein the processor of the mobile communication deviceis operable to process the dose data to determine information about auser's health associated with the amount of medicine dispensed from theinjection device, and wherein the mobile communication device transfersthe information about the user's health to the one or more cloudcomputers for inclusion in a medical record of the user.
 24. The deviceof claim 21, wherein the medicine includes insulin, wherein the softwareapplication program product further includes instructions operable togenerate a user interface that displays the dose data associated withdispensed insulin on the display of the mobile communication device. 25.The device of claim 24, wherein the software application program productfurther includes instructions operable to calculate a recommended doseof the insulin in a dose calculator module, and wherein the userinterface further displays a user input prompt associated with a mealsize that corresponds to a predetermined amount of carbohydrates that auser of the system can enter into the dose calculator module tocalculate the recommended dose of insulin.
 26. The device of claim 25,wherein the mobile communication device is operable to receive glucosedata from an external glucose monitor device.
 27. The device of claim26, wherein the glucose data is received at the software applicationfrom a data transfer provided by a second software application residenton the mobile communication device, wherein the second softwareapplication is associated with the external glucose monitor device or isassociated with a health information repository application.
 28. Thedevice of claim 21, wherein the sensor of the injection device includesan encoder, wherein the plunger includes a screw component, and whereinthe encoder is operable to detect a replacement of the cartridge basedon detecting a retraction of the screw component.
 29. The device ofclaim 21, wherein the mobile communication device includes a globalpositioning system (GPS) to produce location data corresponding to themobile communication device, and wherein the software applicationprogram product further includes instructions operable to process thelocation data of the mobile communication device when the dose data isreceived from the injection device that indicates an estimated locationof the injection device.
 30. The device of claim 29, wherein thesoftware application program product further includes instructionsoperable to display the estimated location of the injection device on amap for a user of the system to locate the injection device.
 31. Thedevice of claim 21, wherein the software application program productfurther includes instructions stored thereon operable to cause themobile communication device to generate a notification to a caregivervia one or both of a text message and an email indicative of the dosedata.
 32. The device of claim 21, wherein the injection device furtherincludes a force sensor operable to detect an external force applied toa needle assembly of the injection device that indicates contact of theinjection device with a user.
 33. The device of claim 32, wherein thesoftware application program product further includes instructionsoperable to cause the mobile communication device to process thedetected external force signals to verify that the last dispensing eventwas the injection dose.
 34. The device of claim 21, wherein the mobilecommunication device includes a camera operable to capture images, andwherein the software application program product further includesinstructions operable to process a captured image of a bar code on thecartridge and determine an identification of the medicine in thecartridge.
 35. The device of claim 21, wherein the software applicationprogram product further includes instructions operable to generate auser interface that displays a history of dispensed doses.
 36. Thedevice of claim 35, wherein the software application program productfurther includes instructions operable to display a user selection onthe user interface that allows a user of the system to indicate whethera dispensed dose in the history of dispensed doses was a prime dose oran injection dose.
 37. The device of claim 21, wherein the medicineincludes insulin, and wherein the software application program productfurther includes instructions operable to calculate a total daily dosedetermined to be an average sum of all insulin delivered including longacting insulin and short acting insulin over the course of a day. 38.The device of claim 21, wherein the software application program productfurther includes instructions stored thereon operable to cause themobile communication device to generate a drug confusion alertindicative of (a) a potential drug interaction or (b) an incorrectdelivery of the drug in response to a comparison of a particularinjection event with one or both of an electronic medical record or aphysician order.
 39. The device of claim 21, wherein the mobilecommunication device is a smartphone, a tablet, or a wearable computingdevice including a smartwatch or smartglasses, wherein the mobilecommunication device is in communication with one or more cloudcomputers networked in a communication network through the Internet. 40.The device of claim 21, wherein the injection device also includes asoftware application program product stored in the non-transitory memoryof the injection device and including instructions operable to cause theinjection device to process the one or more of the dose data to form thedose dispensing sequence such that the dispensing events of the dosedispensing sequence all occur in temporal proximity of one another thatspan less than the predetermined temporal threshold, and the lastdispensing event in the dose dispensing sequence is identified as theinjection event and the one or more of the dispensing events other thanthe last dispensing events in the dose dispensing sequence areidentified as the priming events.
 41. An injection device foradministering a medicine to a patient, comprising: a housing including amain body structured to include a chamber to encase a cartridgecontaining medicine upon loading of the cartridge in the chamber; a dosesetting and dispensing mechanism to set and dispense a particular doseof the medicine from the cartridge, the dose setting and dispensingmechanism including a dose knob, a shaft, and a plunger, wherein thedose knob is rotatable to cause the shaft to move to a positionproportional to a set dose of the medicine, and wherein the dose knob ismoveable to cause the shaft to drive the plunger to dispense themedicine from the cartridge; a sensor to detect a dispensed dose, aneedle assembly to penetrate the skin of a user for dispensing themedicine, an injection sensor operable to detect a signal indicative ofproximity between the needle assembly and the user, and an electronicsunit in communication with the sensor unit, the electronics unitincluding a processor and a non-transitory memory to process thedetected dispensed dose and time data associated with a dispensing eventto generate dose data, a power source to provide electrical power to theelectronics unit, and a transmitter operable to wirelessly transmit thedose data to a mobile communication device, the mobile communicationdevice including a software application program product stored in amemory of the mobile communication device and including instructionsoperable to cause the mobile communication device to process the dosedata associated with the medicine dispensed from the injection device,and process the detected signal indicative of proximity to assign thedetected dispensed dose as an injection dose.
 42. The device of claim41, wherein the injection sensor includes a capacitive sensor.
 43. Thedevice of claim 41, wherein the mobile communication device includes acamera operable to capture images, and wherein the software applicationprogram product further includes instructions operable to process acaptured image of a bar code on the cartridge and determine anidentification of the medicine in the cartridge.
 44. The device of claim41, wherein the software application program product further includesinstructions operable to generate a user interface that displays ahistory of dispensed doses.
 45. The device of claim 44, wherein thesoftware application program product further includes instructionsoperable to display a user selection on the user interface that allows auser of the system to indicate whether a dispensed dose in the historyof dispensed doses was a prime dose or an injection dose.
 46. The deviceof claim 41, wherein the medicine includes insulin, and wherein thesoftware application program product further includes instructionsoperable to calculate a total daily dose determined to be an average sumof all insulin delivered including long acting insulin and short actinginsulin over the course of a day.
 47. The device of claim 41, whereinthe sensor of the injection device includes an encoder, wherein theplunger includes a screw component, and wherein the encoder is operableto detect a replacement of the cartridge based on detecting a retractionof the screw component.
 48. The device of claim 41, wherein the mobilecommunication device includes a global positioning system (GPS) toproduce location data corresponding to the mobile communication device,and wherein the software application program product further includesinstructions operable to process the location data of the mobilecommunication device when the dose data is received from the injectiondevice that indicates an estimated location of the injection device. 49.The device of claim 48, wherein the software application program productfurther includes instructions operable to display the estimated locationof the injection device on a map for a user of the system to locate theinjection device.
 50. The device of claim 41, wherein the medicineincludes insulin, wherein the software application program productfurther includes instructions operable to (i) generate a user interfacethat displays the dose data associated with dispensed insulin on thedisplay of the mobile communication device, and (ii) to calculate arecommended dose of the insulin in a dose calculator module of thesoftware application program product, and wherein the user interfacefurther displays a user input prompt associated with a meal size thatcorresponds to a predetermined amount of carbohydrates that a user ofthe system can enter into the dose calculator module to calculate therecommended dose of insulin.
 51. The device of claim 41, wherein themobile communication device is operable to receive glucose data from anexternal glucose monitor device, wherein the glucose data is received atthe software application from a data transfer provided by a secondsoftware application resident on the mobile communication device,wherein the second software application is associated with the externalglucose monitor device or is associated with a health informationrepository application.
 52. The device of claim 41, wherein theinjection device also includes a software application program productstored in the non-transitory memory of the injection device andincluding instructions operable to cause the injection device to processthe dose data associated with the medicine dispensed from the injectiondevice, and process the detected signal indicative of proximity toassign the detected dispensed dose as the injection dose.